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Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants

Oral Nystatin Prophylaxis to Prevent Systemic Fungal Infection in Very Low Birth Weight Preterm Infants: a Randomized Controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03390374
Enrollment
95
Registered
2018-01-04
Start date
2010-10-31
Completion date
2013-01-31
Last updated
2018-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungal Infections Systemic

Keywords

Nystatin, Fungal colonization, Systemic fungal infections

Brief summary

This study determines the effectiveness of oral nystatin as prophylaxis in order to prevent systemic fungal infection in very low birth weight preterm neonates. 47 participants received oral nystatin and 48 participants received sterile water as part of oral hygiene.

Detailed description

Oral nystatin is an effective and safe alternative fungal prophylaxis. Some previous studies (1 randomized controlled trial and 4 observational studies) showed that oral nystatin prophylaxis reduce fungal colonization and decrease risk of systemic fungal infection in very low birth weight infants. Nystatin is a non-absorbable antifungal agent with minimal side effects that works by binding on the major component of fungus cell membrane and causes death of the fungus. Its efficacy as fungal prophylaxis is comparable with Fluconazole but does not linked to drug-induced liver injury. To determine this effectivity, we recruit eligible neonates who are admitted in our neonatal intensive care unit and randomly assign them into 2 groups once noted written parental consent. One group is given nystatin via oral and/or orogastric tube and the other group only receives sterile water as part of oral hygiene. Weekly fungal surveillance cultures (oropharyngeal and rectal) are done to evaluate colonization. Further examinations (blood/cerebrospinal fluid/deep tissue/urine culture) are done once noted clinical signs of systemic fungal infections. Data analysis is conducted with intent-to treat approach. Significance testing is done by chi-square or fisher's exact test as needed.

Interventions

DRUGNystatin Oral

Nystatin oral suspension

Sponsors

Dr Cipto Mangunkusumo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

The participants is randomly allocated into 2 study groups (nystatin group and control group) during study period

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
No

Inclusion criteria

* Gestational age \<= 32 weeks and/or birth weight \<=1500 grams * 1 or more systemic fungal infection risk factors (antibiotic therapy, intravenous access, endotracheal tube, orogastric tube, urinary catheter, corticosteroid therapy, parenteral nutrition, theophylline therapy)

Exclusion criteria

* Suspected of having necrotizing enterocolitis within 72 hours after birth, cyanotic congenital heart disease, chromosomal defects, or critical conditions whom were not expected to live more than 72 hours after birth

Design outcomes

Primary

MeasureTime frameDescription
Fungal colonization1 to 6 weeksWeekly oropharyngeal and rectal fungal surveillance results are evaluated. Colonization is considered positive if yeast cells were found on either oral or rectal specimen
Systemic fungal infection1 to 6 weeksCulture of blood, cerebrospinal fluid, deep tissue, or urine is evaluated in participants with symptoms/signs of systemic infection. Proven systemic fungal infection is defined as a positive blood, cerebrospinal fluid, deep tissue, or urine culture (\> 10.000 or more colony forming unit/mL from sterile bladder catheterization or suprapubic aspiration)

Secondary

MeasureTime frameDescription
Mortality rates1 to 6 weeksFungal and overall related mortality rates
Nystatin-related adverse drug reactions1 to 6 weeksAny side effects of nystatin as reported in references

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026